Summary of MedSun Reports Describing Problem With Patient AC-Powered Lifts
MedSun: Newsletter #59, April 2011
An AC-powered lift is an electrically powered device either fixed or mobile, used to lift and transport patients in the horizontal or other required position from one place to another, as from a bed to a bath. The device includes straps and slings to support the patient (21 C.F.R. pt 880.5500).
Over the past 2 years, MedSun has received 7 adverse event reports with ac-powered patient lift devices manufactured by ArjoHuntleigh, Waverly Glen Systems, Joerns Healthcare, and Liko. The reports were submitted by 7 hospitals between January 2009 and January 2011.
The reported device problems were (each problem listed was reported once):
• Component removal and patient falling on top of the mounting bar
• Sling fraying
• Lift support post sliding out of position
• Sling strap cuff too long and interfering with sensor
• Sling metal ring sliding out of position
• Lift not able to go to lower position
• Report of lift dropping too fast
None of the reports involved patient death. The patient injuries listed below were reported in 2 of 7 reports (each injury listed was reported once):
• Significant injury to the abdomen requiring surgical intervention
• Minor bruises on the face
Of the reports that listed patient age, one report had a patient age listed as less than 21 years and 5 had patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 3 reports involved female patients and a total of 3 reports involved male patients. Of the reports that listed patient weight, 3 reports involved obese or morbid patients.
These MedSun reports listed above, in addition to manufacturer, healthcare, and voluntary reports contributed to FDA awareness of the device problems.
The following recall is associated with ac-powered patient lifts since 2009. The MedSun reported events may or may not be involved in the recall listed.
Recall Number: Z-1990-2009
Date Posted: August 31, 2009
Product: BHM Combi Sling, 100% Polyester Shell/100% Polyester Strap; soft polyester net fabric sling for ceiling and floor patient lifts; BHM, Magog, Canada, made in China. Part 626002: Combi Deluxe - Medium, capacity 68-113 kg, 150-250 lbs; Part
626002M: Combi Mesh Deluxe - Medium, capacity 68-113 kg, 150-250 lbs; Part
626002C Combi Sling Deluxe Small, capacity 20-68 kg, 45-150 lbs; Part 626002C-M
Combi Sling Mesh Deluxe Small, capacity 20-68 kg, 45-150 lbs; Part 626003: Combi
Deluxe - Large, capacity 113-272 kg, 250-600 lbs; Part 626003M: Combi Mesh
Deluxe - Large, capacity 113-272 kg, 250-600 lbs; and Part 626003X: Combi
Oversize Heavy Duty, capacity 113-272 kg, 250-600 lbs. Between 2004 and 2006,
the Combi Slings were labeled as BHM Medical Inc. (800) 868-0441, 100% Polyester
Shell/100% Nylon Strap, made in Canada. Prior to 2004, the slings were labeled
Medi-Man, 100% Polyester Shell, Rehabilitation Products Inc., Mississauga,
Ontario, Canada L5T 1X7, made in Canada. The accessory is intended to be used
with patient lift for the transfer of patient in hospitals, nursing homes, or other health care facilities by trained caregivers.
Code Information: All lots of BHM/Medi-man Combi Slings released prior to 2/1/09: Part Numbers 626002, 626002M, Part 626002C, Part 626002C-M, Part 626003, Part 626003M and Part 626003X.
Recalling Firm/Manufacturer:B.H.M. Medical, Inc. 2001 Tanguay Street Mago, QC
Action: Arjo sent "Urgent Device Recall Customer Notification" cover letters dated April 15, 2009 to the end user accounts who received the affected BHM/Medi-Man Combi Slings, to the attention of the Administrator/Risk Manager, advising them of the potential for possible stitching failure that could lead to a hazardous situation. Enclosed with the letter was a copy of the BHM Medical Field Safety Notice, FSN 10/2009/ca, dated April 3, 2009 which was sent to their BHM customers in the U.S. on April 7, 2009. The FSN identified the part numbers of the BHM/Medi-Man Combi Slings, described the potential health hazard, and listed the actions to take. The accounts were instructed to inspect and assess their slings' suitability for use per the Slings Maintenance Instructions. If the sling is showing this kind of breakage, the account was instructed to remove it from use and discard it immediately. If the inspection reveals no deterioration of the stitching, the sling is safe to use. The accounts were requested to complete and return the enclosed FSN receipt form within 10 days, acknowledging the receipt and understanding of the letter, and indicating the number of slings in use prior to inspection, the number of slings in use after the inspection, and the number of slings rejected. The accounts will be contacted for the replacement of their eligible old slings (in use up to two years).
Recall Information online available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81859
The following table lists MedSun reports that are described in the device problem summary above.
Note: The reports have been edited for clarity.
|Device (Manufacturer, Brand Name)||Device Identifiers (Model Number, Catalog Number)||Event Description|
|ArjoHuntleigh, Sara Plus Advanced Standing and Raising aid ||NA, NA||A patient was admitted for a planned orthopedic surgery to apply an external fixator to their right lower extremity. Post-surgery, the patient was assisted up into a wheelchair by staff. The pateint later indicated she was ready to go back to bed and staff began to assist with the transfer. During that transfer the patient lost her gait so a staff member grabbed the "Sit and Stand" to help with the transfer procedure. Once staff set up the lift, it was noted the shin guard portion of the foot plate was in the way of the external fixator on her right leg. Staff then removed the shin guard to facilitate the transfer. The patient was unable to stand and perform the transfer and was guided to the floor. Once on the floor, the patient complained of pain and staff noted that she had fallen on a portion of the lift equipment. The patient was moved off the equipment and assisted back to bed with a full lift. A physician quickly came to evaluate the pateint and it was determined the patient sustained a significant injury to her abdomen, one requiring surgical intervention for the treatment of her wound. It was determined the patient fell on top of the bar that would hold the shin guard, causing significant injury. |
|Waverly Glen Systems, NA||C-625, NA||From a sister hospital it was learned that a patient weighing approximately 620 pounds was lifted from the bed to the chair. For this transfer, two lifts were used in tandem. As the patient was lifted to the chair, a piece of the bottom lift fell down, while the black lift belt began to fray in one place. Maintenance was made aware and they came to repair the piece that fell. During this repair, they said that when the patient is discharged they would repair the frayed belt but to go ahead and use it until then. As the patient was being transferred back to bed the belt began to fray in two additional places. There was no patient injury in this lift transfer, only potential for harm.|
|Joerns Healthcare, Voyager Easy Track ||Model: 98000, NA||Patient was being transferred with voyager lift from his bed to an electric wheel chair. While positioned directly above the chair, one of the supports of the lift slid out of position causing the patient to fall on to the floor. At the time of this event, the patient was a quadriplegic and wearing a halo brace. This device is a portable ceiling type lift. This lift runs across a guide rail that is mounted to two posts that are wedged from the floor to the ceiling on either side of the bed. During the use of the device in this event, the lift was set up in a patient's room. The posts were wedged up against a false ceiling, or hung ceiling tile system that is only supported by an aluminum infrastructure.|
|ArjoHuntleigh, MaxiSky 600 Patient Lift ||Model: LD10211, NA ||This report is intended to communicate a manufacturing issue that has not impacted a particular patient yet. Our institution has about 70 Arjo lifts in service and this report is intended to illustrate the problematic interaction between the lift device and the new replacement patient lifting strap. Currently, the replacement lifting straps have a longer sewing cuff than the originals. After routine replacement of the strap; the lift was tested. During this test, it was cycled from the fully retracted to the fully deployed state. While fully deployed, or all the way out, it was discovered that the longer sewing cuff interfered with the sensor that measures when the strap is fully retracted. The lift would not retract because the sensor indicated it already was fully retracted nor would it deploy further as it was at the end of the strap. The result is that the patient stretcher was suspended in mid-air and it would no longer respond to hand control input. When the lift was occupied by a patient, the patient would have to be manually lifted out, and placed on the bed. This poses a risk for both staff and patients. We are emailing companion video to MedSun illustrating the problem. The sewing cuff was too long and caused the lift to 'freeze' in the fully deployed position.|
|Liko, Viking ||Viking M, 2040005||A patient was being lifted out of bed to reclining chair using a patient lift device. Mid-transfer one of the metal rings popped off and one of the lower pad loops came out of the device. The patient started to slide out of the pad, was caught, and then transferred to the chair safely without incident.|
|ArjoHuntleigh, :Maximove ||KMBB4ELU2FUS, NA ||Patient was being transferred to the commode by PT/OT [Physical Therapy/Occupational Therapy]. Once the patient was lifted in the air; the Maximove would not lower from the remote, or from the controls on the lift. Batteries were exchanged and that did not fix problem. The other lift was brought in as a back up. The lift was tried again and it worked. Staff had forgotten about the emergency release.|
|Joerns Healthcare. Hoyer ||HML 400, NA ||OT/PT [Physical Therapy/Occupational Therapy] were attempting to lift a patient with a manual Hoyer lift. During the lift, the staff dialed the button to lower the patient slightly. The Hoyer lift lowered the patient to a point just above the floor; yet not touching. Three staff were assisting in the lift procedure, and a fourth came to assist and support the patient. The patient was not injured but was startled. Staff offered reassurance and comfort to the patient, as did her mother.|